E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
study is conducted on healthy volunteers, no medical condition is
investigated |
|
E.1.1.1 | Medical condition in easily understood language |
study is conducted on healthy volunteers, no medical condition is
investigated |
|
E.1.1.2 | Therapeutic area | Body processes [G] - Physiological processes [G07] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
given the role of PDE enzymes in the process of gastric relaxation on the one hand and posibble relation between impaired gastric accommodation and satiation on the other hand, we aimed to investigate the effect of sildenafil on the relation between gastric motility, gastric emptying and food intake during nutrient infusion. |
|
E.2.2 | Secondary objectives of the trial |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Healthy volunteers will be recruited from an existing mailing list. The
volunteers will have to agree to participate in both studies as described
below. In total 20 healthy volunteers (18-45 years) will be recruited |
|
E.4 | Principal exclusion criteria |
Subjects are excluded from participation if:
• Their age is not between 18 and 45 years old.
• They have relevant underlying disease (cardia, pulmonary, metabolic,
kidney or liver disease, … )
• They have a history of gastric surgery, or recurrent or intermittent upper gastrointestinal symptoms (upper abdominal pain, nausea, vomiting, bothersome fullness or early satiation, heartburn,
regurgitation,…)
• They have a history of allergy to several types of drugs or food.
• There is a possibility of becoming pregnant during the study period.
• Body mass index > 25 |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Intragastric pressure profiles, magnitude of initial pressure drop and slope of recovery of intragastric pressures during continued infusion of
a nutrient drink will be compared. The experiment is finished at maximum satiation.
For gastric emptying, gastric emptying parameters after ingestion of a standard meal will be compared. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
after ending of all experiments |
|
E.5.2 | Secondary end point(s) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
|
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
last visit of last subject |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |